Preeclampsia PostpartumEarly Phase 1NCT05937841
Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
A Early Phase 1 study testing Compound 21 in people with Preeclampsia Postpartum, run by Anna Stanhewicz, PhD at 1 site in United States.
Trial summary
Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to impaired endothelial function and dysregulation of the angiotensin system that occurs during the… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia Postpartum
- What is being tested?
- Compound 21
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2023to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women who had preeclampsia and women who did not have preeclampsia
- 12 weeks to 5 years postpartum
- 18-45 years old
Who cannot join
- history of hypertension or metabolic disease before pregnancy
- history of gestational diabetes
- skin diseases
- current tobacco use
- current antihypertensive medication
- statin or other cholesterol-lowering medication
Show all 10Show fewer
- currently pregnant or planning to become pregnant
- body mass index less than 18.5 kg/m2
- allergy to materials used during the experiment.(e.g. latex),
- known allergy to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to impaired endothelial function and dysregulation of the angiotensin system that occurs during the preeclamptic pregnancy and persists postpartum, despite the remission of clinical symptoms. The purpose of this investigation is to determine the mechanisms contributing to this lasting blood vessel damage caused by reduced endothelial function in women who have had preeclampsia compared to women who had a healthy pregnancy. Identification of these mechanisms and treatment strategies may lead to better clinical management of cardiovascular disease risk in these women.
The purpose of this study is to examine the microvascular differences in women who have had preeclampsia following activation of protective angiotensin receptors in the skin. This will help increase understanding of the mechanisms of angiotensin II receptors in these women, and how activation of these receptors may restore microvascular function.
In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) the investigators examine the blood vessels in a dime-sized area of the skin.
- Conditions
- Preeclampsia Postpartum
- Being tested
- Compound 21
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound 21Drug
AT2R sensitivity: compound 21, and compound 21+ L-NAME (nitric oxide synthase inhibitor) are locally and acutely delivered to the cutaneous microvasculature to assess AT2R-mediated dilation and role of nitric oxide in this response
Local heating: compound 21 is locally and acutely delivered to the cutaneous microvasculature during local heating of the skin to assess endothelium-dependent dilation, L-NAME is added to assess nitric oxide-dependent dilation during this response
| Study group | Role | What they receive |
|---|---|---|
| assessment of microvascular function | Experimental | The investigators use intradermal microdialysis to deliver compound 21 and L-NAME to the cutaneous microvasculature Receives: Drug: Compound 21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microvascular blood flow response to local compound 21 treatment measured by laser-Doppler flowmetry
Cutaneous vascular vasodilator response (cutaneous conductance; %max) to exogenous compound 21 perfusion; intradermal microdialysis for the local delivery of compound 21
Measured: post 1 hour of skin perfusion
Change in microvascular endothelial function following local C21 treatment compared to placebo treatment measured by laser-Doppler flowmetry
Cutaneous vascular vasodilator response (cutaneous conductance; %max) to local heating of the skin; intradermal microdialysis for the local delivery of compound 21 compared to control (Ringer's solution), followed by L-NAME infusion to quantify NO-dependent response
Measured: post 1 hour of skin perfusion
Secondary outcomes (1)
Angiotensin receptor expression in endothelial cells
Quantify expression of angiotensin II receptor expression in biopsied endothelial cells
Measured: a total of 1 time during the study, within ~4 weeks following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start28 Jun 2023
- Primary completion12 Aug 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preeclampsia PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Stanhewicz, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Stanhewicz, PhD, University of Iowa
- Investigators
- Anna Reid-Stanhewicz, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937841
- Sponsor's protocol ID
- 202303202
- Status last verified
- Oct 2026
- First submitted
- 21 Jun 2023
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwartz KS, Sun M, Jalal DI, Santillan MK, Stanhewicz AE. Reduced AT2R Signaling Contributes to Endothelial Dysfunction After Preeclampsia. Hypertension. 2025 May;82(5):904-913. doi: 10.1161/HYPERTENSIONAHA.124.24098. Epub 2024 Dec 26.
PubMed 39723536
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
- ClinicalTrials.gov ID
- NCT05937841
- Acronym / sponsor ID
- 202303202
- Conditions
- Preeclampsia Postpartum
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anna Stanhewicz, PhDUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to impaired endothelial function and dysregulation of the angiotensin system that occurs during the preeclamptic pregnancy and persists postpartum, despite the remission of clinical symptoms. The purpose of this investigation is to determine the mechanisms contributing to this lasting blood vessel damage caused by reduced endothelial function in women who have had preeclampsia compared to women who had a healthy pregnancy. Identification of these mechanisms and treatment strategies may lead to better clinical management of cardiovascular disease risk in these women.
The purpose of this study is to examine the microvascular differences in women who have had preeclampsia following activation of protective angiotensin receptors in the skin. This will help increase understanding of the mechanisms of angiotensin II receptors in these women, and how activation of these receptors may restore microvascular function.
In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) the investigators examine the blood vessels in a dime-sized area of the skin.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assessment of microvascular function | Experimental | Drug: Compound 21The investigators use intradermal microdialysis to deliver compound 21 and L-NAME to the cutaneous microvasculature |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women who had preeclampsia and women who did not have preeclampsia
- 12 weeks to 5 years postpartum
- 18-45 years old
Key exclusion criteria (10 listed)
- history of hypertension or metabolic disease before pregnancy
- history of gestational diabetes
- skin diseases
- current tobacco use
- current antihypertensive medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound 21AT2R sensitivity: compound 21, and compound 21+ L-NAME (nitric oxide synthase inhibitor) are locally and acutely delivered to the cutaneous microvasculature to assess AT2R-mediated dilation and role of nitric oxide in this response Local heating: compound 21 is locally and acutely delivered to the cutaneous microvasculature during local heating of the skin to assess endothelium-dependent dilation, L-NAME is added to assess nitric oxide-dependent dilation during this response | Drug | assessment of microvascular function |
Primary outcome
Change in microvascular blood flow response to local compound 21 treatment measured by laser-Doppler flowmetry
Time frame: post 1 hour of skin perfusion
Cutaneous vascular vasodilator response (cutaneous conductance; %max) to exogenous compound 21 perfusion; intradermal microdialysis for the local delivery of compound 21
Change in microvascular endothelial function following local C21 treatment compared to placebo treatment measured by laser-Doppler flowmetry
Time frame: post 1 hour of skin perfusion
Cutaneous vascular vasodilator response (cutaneous conductance; %max) to local heating of the skin; intradermal microdialysis for the local delivery of compound 21 compared to control (Ringer's solution), followed by L-NAME infusion to quantify NO-dependent response
1 secondary outcome
Angiotensin receptor expression in endothelial cells
Time frame: a total of 1 time during the study, within ~4 weeks following enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Derived from this study: PubMed 39723536Schwartz KS, Sun M, Jalal DI, Santillan MK, Stanhewicz AE. Reduced AT2R Signaling Contributes to Endothelial Dysfunction After Preeclampsia. Hypertension. 2025 May;82(5):904-913. doi: 10.1161/HYPERTENSIONAHA.124.24098. Epub 2024 Dec 26.
- Individual participant dataSharing planned: No
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A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Reid-Stanhewicz, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Compound 21 in people with Preeclampsia Postpartum, run by Anna Stanhewicz, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microvascular blood flow response to local compound 21 treatment measured by laser-Doppler flowmetry (time frame: post 1 hour of skin perfusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05937841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.